HANDBOOK OF GENERIC DRUG DEVELOPMENTANDA DEVELOPMENTInternational Association

Drug 20× Ø02 Manufacturers

High Quality Low Cost Drug Development & Manufacturing Excellence World WideInnovative & Generic

HANDBOOK OF
DRUG DEVELOPMENTSeriesPart I - Drug Development - CMS
Part II - Drug Development
CMC/ANALYTICAL/VALIDATIONUSCHEMISTRY MANUFACTURING CONTROLKnow How Technology&EU
DOSSIERS
Know How Technology

HANDBOOK OF GENERIC DRUG DEVELOPMENT+120 Title Specific DEVELOPMENT SERIESHANDBOOK OF GENERIC DRUG DEVELOPMENTI n t e r n a t i o n a l

ANDA DEVELOPMENTA s s o c i a t i o n

Drug20×Ø01Manufacturers
High Quality Cost Effective Drug Development & M anufacturing Excellence World WideI n n o v a t i v e&G e n e r i c

HANDBOOK of DRUG DEVELOPMENT+120 Title Specific SeriesPart I - CMC DATAPart II - ANALYTICAL STABILITY VALIDATION DATA
Generic Development ISSN Series number 0793 7407
Generic Development ISSN Series number 0793 7792 - Electronic Issue (Disk/CD ROM)
IAGIM's HBGD HANDBOOKS KNOW-HOW SERIES are available in the most common dosage
forms namely solid, semisolid and liquid dosage forms. The presentation of the actual data is basedon commercial manufactured production batches and the format of all sections is similar to the datain the standard ANDA or EU Dossier. Commercial batches based on IAGIM technology are suitable
for, and are in standard commercial production worldwide.

Drug Development Series
Alendronate Sodium
Alendronate Sodium

Aluminium / Magnesium
Amitriphyline HCl
Azithromycin
Azithromycin
Azithromycin
Atenolol EU
Atenolol US
Amoxicillin
Bisoprolol Fumerate/HCTZ=ZIAC
Bromhexine Hydrochloride
Bromocriptine Mesylate
Bupropion
Buspirone HCl
Carbamazepine=Geigy (EU + US)
Carbamazepine=Geigy ChewTabs
Carbamazepine (Extended Release)≡ Geigy TEGRATOL 400 mg XR™
Carbidopa/Levodopa
Carbidopa/Levodopa
Carbidopa/Levodopa
Carbidopa/Levodopa ER
Cefaclor Oral Suspension USP
Cefaclor Oral Suspension USP
Cefaclor Oral Suspension EU
Cefaclor
Cefalexin (≡ Keflex)
Cefuroxime Sodium USP
Clonazepam
Tablets USP

FormStrength

Tablets
Tablets
Suspension
Tablets
Suspension
CapsulesTablets
Tablets
Tablets
CapsulesTablets US + EU
Tablets +Syrup
Tablets
Tablets
Tablets
Tablets
ChewTabs
ER Coated Tab
Tablets
TabletsTablets
Tablets
Suspension
Suspension
Suspension
CapsulesCapsulesVials
Tablets USP

HANDBOOK OF GENERIC DRUG DEVELOPMENT

5 - 10 mg

40 mg
10 mg
200 mg
250 /600 mg
600 mg50 /100 mg
50 /100 mg
250/500mg
5,10, 25/6.25mg
8mg
2.5mg
75.0/100 mg
5 mg /10 mg
200mg
100 mg
400 mg10/100 mg
25/100 mg
25/250mg
50/200mg
125 /187 mg/5mL

250/375 mg/5mL
250 mg/5mL
250/500mg
250/500mg
750-1500mg
0.5/1.0/ 2.0mg

Level

Part

US CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMC

1&21&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&21&2
1&21&21&21&2
1&21&2

US CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMC

1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2+120 Title Specific DEVELOPMENT SERIESHANDBOOK OF GENERIC DRUG DEVELOPMENT

ANDA DEVELOPMENTHANDBOOK of DRUG DEVELOPMENT+120 Series
Generic Development ISSN Series number 0793 7407
Generic Development ISSN Series number 0793 7792 - Electronic Issue (Disk/CD ROM)

Clomiphene Citrate
Clomipramine HCl
Cloramphenicol / Prednisolone
Cimetidine Chew Tablets
Diclofenac Potassium
Diclofenac K + Misoprostol 200mcg
Diclofenac Sodium + Misoprostol 200mcg
Diclofenac Sodium
Diclofenac Sodium
Diclofenac Sodium
Dorzolamide HCL Ophthalmic
Etodolac ≡ Wyeth Lodine
Etodolac ≡ Wyeth Lodine™
Etodolac ≡ WyethAyerst Lodine XL™
Enalapril Maleate
Etidronate Disodium
Famotidine ≡ Merck's Pepsid
Famotidine ≡ Merck's Pepsid ACFelodipine
Felodipine Extended ReleaseFluocinolone acetate
Fluozamine Malate≡Solway's Luvox™
Flunisolide Hemihydrate solution
Flunitazapam
Fluoxetine
FluoxetineFusemide
Gabapentin (≡Neurontin-Park Davis)
Gabapentin (≡Neurontin-Park Davis)
Gemfibrosil
Gemfibrosil
Glibenclamide
Glipizide Extended Release
Ibuprofen
Imodium
Isosorbide Mononitrate
Ketorolac Tromethamine
Levodopa/ Benserazide HCl
Labetalol HCL (100; 200; 300mg)
Loperimide
Lovistatin ≡ Ayerst
Mesalamine(Enteric Coated)
Metformin HCl≡GLUCOPHAGE® BMS
Miconazole/Hydrocortisone
Miconazole Nitrate
Miconazole Nitrate
Nabumatone

Tablets USP
CapsulesCreamTablets
Tablets
Tablets
Tablets
Tablets
Tablets SR
Clear Gel
Solution
Capsules IR
Tablets IR
Tablets ER
Tablets
Tablets
Tablets
ChewTabs
Tablets
Tablets ER
Cream
Tablets
Nasal solution
Tablets
CapsulesTablets DC
CapsulesCapsulesCapsulesTablets
Tablets
Tablets
Tablets ER
Tablets
CapletTablets
Tablets
Tablets
Tablets
Tablets
Tablets
Tablets
Tablets
Cream
Cream
Gel
Tablets

50mg
25 / 50 / 75 mg
3.0 / 0.5%
100 mg25 / 50 mg
25 / 50 mg
50 / 75 mg
50 / 75 mg
100 mg
10 mg/g2%
200/300mg
400/500 mg
400/500/600mg
40 mg
10 / 20 / 40 mg
10mg
5/10mg2.5 / 5 / 10 mg
0.25%
20,50 100mg
1mg/5mL
2 mg
10 / 20 mg
10 / 20 mg
40 mg
100/200 mg
300/400 mg
450 mg
600 mg5 mg
2.5 mg200-800mg
2mg
20 mg
10 mg
200/50 mg
100/200/300mg

2mg
10 20 40mg
400mg
500/850mg
2% + 1%2%
2%
500/750mg

US CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMCUS CMC

1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2

Copyright © 1995-9 by Locum Publishing House Inc. All Rights Reserved. Neither this book nor any part may be reproduced ortransmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming and recording, or by any
information storage and retrieval system, without the permission of the publishers

HANDBOOK OF GENERIC DRUG DEVELOPMENT+120 Title Specific DEVELOPMENT SERIESHANDBOOK OF GENERIC DRUG DEVELOPMENT

ANDA DEVELOPMENTHANDBOOK of DRUG DEVELOPMENT+120 Series
Generic Development ISSN Series number 0793 7407
Generic Development ISSN Series number 0793 7792 - Electronic Issue (Disk/CD ROM)

Naproxen (Enteric Coated)

Tablets DRTablets

250 /375 / 500mg US CMC
220 mgUS CMC
Naproxen Sodium DR
275 / 550mg
US CMC
Naproxen Sodium DR
Tablets DR
Norfloxacin USP
Tablets
400 mgUS CMC
Tablets EU
100, 200, 400 mg US CMC
Ofloxacin ≡TARAVID
Tablets USA
100, 200, 400 mg US CMC
Ofloxacin ≡TARAVID
Oxolamine
Syrup
10 mg/mL
US CMC
Paclitaxel Concentrate for Injection
30/100mg vial
6.0 mg/mL
US CMC
Paracetamol - sugar/dye-free
Syrup
125 mgUS CMC
Paracetamol Chewable Fruit Flavors
Tablets
160 mgUS CMC
400 mgUS CMCPentoxifylline ≡Hoechst 400 XL
Tablets ER
Penfluridol
Capsules
10 mg
US CMCTablets
10+20 mEq
Potassium Chloride 600+1200mg (SR)US CMC
Piroxicam
Capsules
20 mg
US CMC
Quinidine Bisulphate Tetrahydrate
Tablets
250 mgUS CMC
Ranitidine HCl
Tablets
150/300 mg
US CMC
Simvastatin
Tablets
5 / 10mg
US CMC
Simvastatin
Tablets
20 / 40 mg
US CMC
Scopolamine Butylbromide
Tablets
10 mg
US CMC
Selegiline
Tablets
5 /10 mg
US CMC
Sotalol (=Betapace™/ Berlex)
Tablets EU+ US 80, 120
US CMC160 240 mg
Silver Sulphadiazine
Cream1%US CMC
Tamoxifen EU
Tablets
10 / 20 mg
US CMC
Tamoxifen EU
Tablets
30 / 40mg
US CMCTamoxifen US Aqueous Coated
Tablets
10/20/40mg
US CMC
Tamoxifen US Non Coated
Tablets
10/20/40mg
US CMC
Terbutaline Sulfate
Syrup
0.3 mg/mL
US CMCTerazosin
Tablets
1mg / 2mg
US CMCTerazosin
Tablets
5mg / 10mg
US CMC
Terfenadine
Tablets
60 mg
US CMC
Tetrahydrozoline HCl USP
Eye Drops
2,5mg/5mL
US CMC
Ticlopidine
Tablets
250 mgUS CMC
Timolol maleate Drops USP
Eye Drops
0.25 / 0.5%
US CMC
Tolmetin Sod.
Capsules
400 mgUS CMC
Tolmetin Sod.
Tablets
600 mgUS CMC
Trazodone
Tablets
50/100 mg
US CMC
Trazodone
Tablets
150 mgUS CMC
Tretinoin
Cream USP
0.025%US CMC
Sulfamethoxazole Trimethoprim
Tablets USP
80/400mg
US CMC
Sulfamethoxazole Trimethoprim
Tablets USP
160/800mg
US CMC
Sulfamethoxazole Trimethoprim
Suspension
80/400mg
US CMC
Sodium Valproate
Syrup
200mg/5mL
US CMC
Verapamil Hydrochloride
Tablets
40/80/120mg
US CMCAN ONGOING SERIES - NEW ADDITIONS ADDED TO SERIES

1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&21&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2
1&2

Generic Development ISSN Series number 0793 7407
Generic Development ISSN Series number 0793 7792 - Electronic Issue (Disk/CD ROM)
Second International Edition - 02 (First to Fourth Print). Fourth printing published and distributed in UK, US, EU, Israel, Asia, and Japan in January
1998 by Locum International Publishing House (Houston, Israel, South Africa) in Hard Cover; Soft and Spiral Cover; Electronic Diskette; and e-mailattachment versions. All print and electronic versions identical in content and format

HANDBOOK OF GENERIC DRUG DEVELOPMENT+120 Title Specific DEVELOPMENT SERIES